- CHF
7.0M ($
7.4M)
of cash and cash equivalents at
December 31,
2022
- ADX71149
Phase 2 study in epilepsy cohort
1 completes part 1
– independent interim review committee
(IRC) recommendation expected
early Q2 2023
Ad Hoc Announcement Pursuant to Art. 53
LR
Geneva, Switzerland,
March 30,
2023 - Addex
Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage
pharmaceutical company pioneering allosteric modulation-based drug
discovery and development, today reported financial results for the
full-year ended December 31, 2022, and provided a corporate
update.
“Our partner, Janssen made excellent progress in
advancing the ADX71149 phase 2 clinical study in epilepsy patients
and we look forward to the recommendation from the independent
interim review committee, established to review the data from part
1,” said Tim Dyer CEO of Addex. “We continue to make solid progress
across our preclinical portfolio. In parallel, we are continuing to
focus on pursuing collaborative arrangements to secure the
financial resources and specialist expertise to advance development
and strengthen our balance sheet.”
2022
Operating Highlights:
- ADX71149 epilepsy Phase 2 study
part 1 completed with Independent interim review committee
recommendation expected early Q2 2023
- Dipraglurant is Phase 2 ready –
future development in PD-LID, post-stroke recovery and pain under
evaluation
- mGlu7 NAM for stress related
disorders, including PTSD - drug candidate selected for IND
enabling studies, with study preparation underway
- GABAB PAM strategic partnership
with Indivior for substance use disorders extended – multiple drug
candidates in clinical candidate selection phase
- GABAB PAM CMT1A, chronic cough and
pain program profiling multiple drug candidates
- Continued to progress with mGlu2
NAM mild neurocognitive disorders program
- M4 PAM schizophrenia program
progressing well through lead optimization
- Partnering discussions across the
portfolio progressing well
- Completed the close-down of
dipraglurant PD-LID development and implemented cost saving
measures
- Completed offering in July 2022
raising gross proceeds of $4.2 million
Key
2022 Financial
Data
CHF’
thousands |
2022 |
2021 |
Change |
Income |
1,445 |
3,153 |
(1,708) |
R&D
expenses |
(14,665) |
(12,840) |
(1,825) |
G&A
expenses |
(7,300) |
(5,819) |
(1,481) |
Total operating
loss |
(20,520) |
(15,506) |
(5,014) |
Finance result,
net |
(284) |
154 |
(438) |
Net loss for the
period |
(20,804) |
(15,352) |
(5,452) |
Basic and diluted
net loss per share |
(0.46) |
(0.45) |
(0.01) |
Net increase /
(decrease) in cash and cash equivalents |
(13,528) |
1,790 |
(15,318) |
Cash and cash
equivalents |
6,957 |
20,485 |
(13,528) |
Shareholders’
equity |
4,913 |
16,931 |
(12,018) |
Financial Summary:
Income is primarily from our funded research
collaboration with Indivior. Income decreased by CHF 1.7
million to CHF 1.4 million in 2022 compared to CHF 3.2 million in
2021. The decrease is a reflection of the positive progression of
the collaboration into late stages of clinical candidate selection
and the transfer of R&D activities to Indivior.
R&D expenses increased by CHF 1.8 million to
CHF 14.6 million in 2022 compared to CHF 12.8 million in 2021,
mainly due to increased outsourced R&D expenses for CHF 1.0
million and increased share-based compensation costs for CHF 0.6
million.
G&A expenses increased by CHF 1.5 million to
CHF 7.3 million in 2022 compared to CHF 5.8 million in 2021,
primarily due to higher share-based compensation costs.
The net loss was CHF 20.8 million in 2022
compared to CHF 15.4 million in 2021. Net loss increased by
CHF 5.5 million, primarily due to our increased
expenses and decreased income. Basic and diluted loss per share
increased to CHF 0.46 for the year ended December 31, 2022,
compared to CHF 0.45 for the year ended December 31, 2021.
Cash and cash equivalents decreased to CHF 7.0
million at December 31, 2022, compared to CHF 20.5 million at
December 31, 2021. This decrease of CHF 13.5 million is mainly due
to our net loss of CHF 20.8 million adjusted for non-cash expense
items such as share based compensation of CHF3.7 million and net
proceeds of CHF 3.7 million from the offering executed on July 22,
2022.
2022
Consolidated Financial
Statements:The full-year 2022 financial
report can be found on the Company’s website in the
investor/download section here.
Conference Call Details:A
conference call will be held today, March 30, 2023, at 16:00
CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial
results. Tim Dyer, Chief Executive Officer and Robert Lütjens, Head
of Discovery - Biology will deliver a brief presentation followed
by a Q&A session.
Joining the Conference
Call:
- Participants are required to
register in advance of the conference using the link provided
below. Upon registering, each participant will be provided with
Participant Dial-in numbers, and a unique Personal PIN.
- In the 10 minutes prior to the
call’s start time, participants will need to use the conference
access information provided in the e-mail received at the point of
registering. Participants may also use the call me feature instead
of dialing the nearest dial in number.
Online Registration:
https://register.vevent.com/register/BI8f6a1aee693c405ebc85b10adfa18648
Webcast URL:
https://edge.media-server.com/mmc/p/7qb5zc3s
About Addex
Therapeutics:Addex Therapeutics is a
clinical-stage pharmaceutical company focused on the development
and commercialization of an emerging class of novel orally
available, small molecule drugs known as allosteric modulators for
neurological disorders. Allosteric modulators offer several
potential advantages over conventional, non-allosteric molecules
and may offer an improved therapeutic approach to conventional
"orthosteric" small molecule or biological drugs. Addex's
allosteric modulator drug discovery platform targets receptors and
other proteins that are recognized as essential for therapeutic
intervention. Addex's lead drug candidate, ADX71149 (mGlu2 positive
allosteric modulator or PAM), developed in collaboration with
Janssen Pharmaceuticals, Inc., is in a Phase 2a proof of concept
clinical trial for the treatment of epilepsy. Addex's second
clinical program, dipraglurant (mGlu5 negative allosteric modulator
or NAM), is under evaluation for future development in a range of
indications. Indivior PLC has licensed Addex’s GABAB PAM program
for the development of drug candidates, with a focus on substance
use disorder. Addex is also advancing a broad preclinical pipeline,
which includes development of a range of GABAB PAMs for CMT1A,
chronic cough and several types of pain, mGlu7 NAM for stress
related disorders, mGlu2 NAM for mild neurocognitive disorders and
depression, M4 PAM for schizophrenia and other forms of
psychosis, as well as mGlu4 PAM and mGlu3 PAM. Addex shares are
listed on the SIX Swiss Exchange and American Depositary Shares
representing its shares are listed on the NASDAQ Capital Market,
and trade under the ticker symbol "ADXN" on each exchange.
Press Contacts:
Tim DyerChief Executive OfficerTelephone: +41 22 884 15
55PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)7968
022075msinclair@halsin.com |
Forward Looking Statements:This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including the ability to discover molecules as part of the
Indivior collaboration, the progress of clinical trials and
preclinical studies, including the timing of data read-outs from
the ADX71149 epilepsy study, and our intended strategic direction.
The words “may,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release, such as receipt of ongoing research payments and timing of
the collaboration conclusion, are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or
results to differ materially from those expressed or implied by any
forward-looking statements contained in this press release,
including, without limitation, uncertainties related to market
conditions. These and other risks and uncertainties are described
in greater detail in the section entitled “Risk Factors” in Addex
Therapeutics’ Annual Report on Form 20-F for the year ended
December 31, 2022, as filed with the SEC on March 30, 2023, the
prospectus supplement and accompanying prospectus and other filings
that Addex Therapeutics may make with the SEC in the future. Any
forward-looking statements contained in this press release
represent Addex Therapeutics’ views only as of the date hereof and
should not be relied upon as representing its views as of any
subsequent date. Addex Therapeutics explicitly disclaims any
obligation to update any forward-looking statements.
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